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. 2007 Jul 18;2007(3):CD001434. doi: 10.1002/14651858.CD001434.pub2

Gupta 2000b.

Methods RCT
 Study aim clearly defined: yes
 Blinded assessor of primary outcome: not stated
 Double blind study; yes
 Participants comparable at baseline for age: yes Sex: yes Duration of complaint: yes
 Inclusion and exclusion criteria specified: yes
 Interventions well described: yes
 Assessment of compliance: not stated
 Intention to treat analysis: yes
 A Priori sample size calculation: not stated
 Fungi identified: yes
 Distribution of species between groups: yes
 Adverse events reported: yes
 Number of drop outs stated: yes
Participants Total evaluable sample size: 237
 Exclusion criteria: white superficial or proximal subungual onychomycosis. Nail dystrophy. Infection which led to epinychium, antifungal therapy 24 weeks prior to study. Treatment setting; Multicentre studies USA
Interventions a. Ciclopirox nail lacquer 8% solution
 Duration: 48 weeks
 Frequency: applied once daily
 b. Placebo solution
 Duration: 48 weeks
 Frequency: applied once daily:
Outcomes Primary outcome: cure
 Secondary Outcomes: Planimetric measurements % affected nail, Global evaluation score 0=cured, 1=excellent improvement, 2=moderate improvement; 3=slight improvement; 4= no change.
 Adverse events: 10 (9%) group a,
 7 (6%) group b.
Data not presented
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear